The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2023-05-12

Brief Summary

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This is multicenter, open-label, 2-part crossover study. Eligible subjects will have metastatic or unresectable solid tumors. This study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline. The treatment phase consists of Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up.

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Detailed Description

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Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This will be an open-label, 2-part, crossover study to assess the effect of food on Oraxol exposure. The study will consist of the following periods: Screening, Baseline, Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up. Part A will assess the effect of food on Oraxol pharmacokinetics. In Part A, subjects will be randomized to the sequence (fed/fasted or fasted/fed conditions) under which they will be administered single-dose treatment after an overnight fast. There will be a minimum of 7 days after Period 1 treatment before subjects cross over to Period 2 treatment. Subjects who have participated in the PK assessments in Part A of the study may continue into Part B, during which Oraxol will be dosed for 3 consecutive days per week under fasting conditions.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fed/ Fasted Treatment Sequence

Subjects will be assigned a fed/fasted sequence.

Fed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration.

Fasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose.

Group Type ACTIVE_COMPARATOR

Oraxol

Intervention Type DRUG

Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.

Fasted/ Fed Treatment Sequence

Subjects will be assigned a fasted/fed sequence.

Fasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose.

Fed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration.

Group Type ACTIVE_COMPARATOR

Oraxol

Intervention Type DRUG

Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.

Interventions

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Oraxol

Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.

Intervention Type DRUG

Other Intervention Names

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Paclitaxel and HM30181AK-US

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent
* Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Measurable disease as per RECIST v1.1 criteria
* Adequate hematologic status
* Adequate liver function.
* Adequate renal function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy of at least 3 months.
* Women must be postmenopausal or surgically sterile.
* Sexually active male subjects must use a barrier method of contraception during the study.
* Able to consume the prescribed meals

Exclusion Criteria

* Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs).
* Received IPs within 21 days or 5 half-lives of the first dosing day, whichever is shorter
* Are currently receiving other medications or radiation intended for the treatment of their malignancy. Hormonal therapy is allowed.
* Women of childbearing potential who are pregnant or breastfeeding.
* Currently taking a concomitant medication, other than a premedication, that is:

* A strong P-glycoprotein (P-gp) inhibitor or inducer.
* An oral medication with a narrow therapeutic index known to be a P-gp substrate.
* Medications known to be strong inhibitors or inducers of cytochrome P450 (CYP) 2C8 or medications known to be strong CYP3A4 inhibitors or inducers.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or any concomitant illness that would limit compliance with study requirements.
* Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease that may interfere with oral drug absorption.
* Cirrhosis of the liver or known active hepatitis B, hepatitis C, or HIV
* History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity-type reaction to Cremophor

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No